MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS GLENOID II PIN D. 2.5MM L.200MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	DWD063
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pin was being used on power and snapped off in the patient.The surgeon had to work to get the broken piece out and added to the case time.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows signs of obvious signs of breakage as it is completely broken into two pieces.The device is bent & highly deformed near the area of the broken tip.Circular and scratched traces are observed at the bent portion of the device (due to friction with other tools).The fracture was caused by an application of excessive torsional load as indicated by a slight material deformation at the breakage surface.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an overstress applied on the tip during use when inserting the device into the guide, drilling and fixing it into the glenoid bone.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the pin was being used on power and snapped off in the patient.The surgeon had to work to get the broken piece out and added to the case time.

• Brand Name: AEQUALIS GLENOID II PIN D. 2.5MM L.200MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15139662
• Report Number: 3000931034-2022-00270
• Device Sequence Number: 12593484
• Product Code: HWE
• UDI-Device Identifier: 03700386931796
• UDI-Public: 03700386931796
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2023
• Device Model Number: DWD063
• Device Catalogue Number: DWD063
• Device Lot Number: 0835AU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown